An interventional study of MEMO Patch and 24-Hour Holter Monitor in Arrhythmia, Palpitations and Syncope, sponsored by HUINNO Co., Ltd. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by HUINNO Co., Ltd · Not applicable, Interventional, and Diagnostic
"This exploratory prospective clinical study aims to evaluate the diagnostic yield of a 7-day adhesive electrocardiographic (ECG) monitoring device (MEMO Patch) in detecting cardiac arrhythmias in patients presenting with palpitations.
Participants who require 24-hour Holter monitoring because of symptoms such as palpitations or dizziness will simultaneously wear a conventional 24-hour Holter monitor and the MEMO Patch. The Holter monitor will be removed after 24 hours, while the MEMO Patch will continue monitoring for a total of 7 days. ECG recordings will be evaluated by cardiologists after technical quality assessment. The study will assess arrhythmia detection, device-related skin adverse events, and participant usability and satisfaction."
"Patients aged 19 years or older who visit the study site with symptoms suggestive of arrhythmia and require 24-hour ambulatory ECG monitoring will be screened after providing written informed consent.
At Visit 1, participants will simultaneously undergo conventional 24-hour Holter monitoring and 7-day ECG monitoring using the MEMO Patch. Participants will record the occurrence and timing of any symptoms in a symptom diary during the monitoring period.
The Holter monitor will be returned after 24 hours. Participants will continue wearing the MEMO Patch for an additional six days and return the device by mail after completion of the 7-day monitoring period.
After technical quality assessment, ECG recordings from both devices will be interpreted by cardiologists. Participants will return approximately one week after completion of monitoring to review the test results. Device usability and participant satisfaction will also be assessed using a questionnaire."
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →HUINNO Co., Ltd is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants simultaneously underwent conventional 24-hour Holter monitoring and continuous ECG monitoring using the MEMO Patch for seven days.
Device: MEMO Patch · Device: 24-Hour Holter Monitor
MEMO Patch is a wearable single-lead adhesive electrocardiographic (ECG) monitoring device for continuous ECG recording. The device is applied simultaneously with a conventional 24-hour Holter monitor at Visit 1 and is worn continuously for 7 days.
Also known as: Adhesive ECG Patch
A conventional 24-hour ambulatory electrocardiographic (ECG) monitor is applied simultaneously with the MEMO Patch at Visit 1 and is used for continuous ECG recording for approximately 24 hours. The Holter monitor is removed at Visit 2.
Also known as: 24-Hour Ambulatory ECG
Rate of Participants with Clinically Significant Arrhythmia
The rate of participants diagnosed with at least one clinically significant arrhythmia will be evaluated based on ECG monitoring. Clinically significant arrhythmias include supraventricular tachycardia (≥3 consecutive beats, excluding atrial fibrillation/flutter), atrial fibrillation/flutter (episode ≥30 seconds), sinus pause (≥3 seconds), second-degree (Mobitz type II) or third-degree atrioventricular block, ventricular tachycardia (≥3 consecutive beats), and polymorphic ventricular tachycardia or ventricular fibrillation.
Time frame: Visit 3 (approximately 14 [±3] days after device application at Visit 1)
Frequency of Skin Adverse Events
The occurrence, frequency, severity, time of onset, and seriousness of skin adverse events associated with MEMO Patch use will be evaluated.
Time frame: Visit 3 (approximately 14 [±3] days after device application at Visit 1)
MEMO Patch Satisfaction and Usability Questionnaire Score
Participant satisfaction and usability of MEMO Patch will be evaluated using a 12-item questionnaire based on a 5-point Likert scale, with scores ranging from 1 to 5. Higher scores indicate better satisfaction and usability.
Time frame: Visit 3 (approximately 14 [±3] days after device application at Visit 1)
Plan to share: No — Individual participant data collected in this study are not planned to be shared with external researchers. Any future sharing would require separate sponsor approval and compliance with applicable privacy, ethical, and institutional requirements.
No publications or documents are linked to this record.
Ran from Mar 2020 to primary completion in Jul 2021, 16 months.
Of 71 industry-sponsored interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's 16 months is close to that.
Counting every sponsor, half of 242 studies reached it within 24 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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